Defibrillator with dynamic ongoing CPR protocol

ABSTRACT

An automated external defibrillator (AED) ( 10 ) having a treatment decision processor ( 28 ) is described which follows a “shock first” or a “CPR first” rescue protocol after identification of a treatable arrhythmia, depending upon an estimate of the probability of successful resuscitation made from an analysis of a patient parameter measured at the beginning of the rescue. The invention may also follow different CPR protocols depending on the estimate. The invention also may use the trend of the measured patient parameter to adjust the CPR protocol either during a CPR pause or after the initial CPR pause. The AED ( 10 ) thus enables an improved rescue protocol.

This application is a U.S. National Phase Application of InternationalApplication No. PCT/IB2011/054772, filed on Oct. 26, 2011, and claimsthe benefit of U.S. Provisional No. 61/409,808, filed on Nov. 3, 2010,and U.S. Provisional No. 61/466,512, filed on Mar. 23, 2011.

The invention relates generally to electrotherapy circuits, and moreparticularly, to a defibrillator which analyzes patient physiologicaldata and determines whether a shock or cardio-pulmonary resuscitation(CPR) therapy should be conducted. More specifically, an AED rhythmclassification, such as a so-called vRhythm score determines the optimalprotocol for CPR, deciding whether, for example, compressions-only CPRor conventional CPR (compressions+breaths) should be performed by theresponder. The trend of the vRhythm score may be utilized to adjust theCPR protocol during the rescue. In addition, the AED rhythmclassification may be used during CPR to help determine whether to stopthe CPR period early in order to deliver an immediate defibrillatingshock.

Defibrillators deliver a high-voltage impulse to the heart in order torestore normal rhythm and contractile function in patients who areexperiencing arrhythmia, such as ventricular fibrillation (“VF”) orventricular tachycardia (“VT”) that is not accompanied by spontaneouscirculation. There are several classes of defibrillators, includingmanual defibrillators, implantable defibrillators, and automaticexternal defibrillators (“AEDs”). AEDs differ from manual defibrillatorsin that AEDs can automatically analyze the electrocardiogram (“ECG”)rhythm to determine if defibrillation is necessary. In nearly all AEDdesigns, the user is prompted to press a shock button to deliver thedefibrillation shock to the patient when a shock is advised by the AED.

FIG. 1 is an illustration of a defibrillator 10 being applied by a user12 to resuscitate a patient 14 suffering from cardiac arrest. In suddencardiac arrest, the patient is stricken with a life threateninginterruption to the normal heart rhythm, typically in the form of VF orVT that is not accompanied by spontaneous circulation (i.e., shockableVT). In VF, the normal rhythmic ventricular contractions are replaced byrapid, irregular twitching that results in ineffective and severelyreduced pumping by the heart. If normal rhythm is not restored within atime frame commonly understood to be approximately 8 to 10 minutes, thepatient will die. Conversely, the quicker that circulation can berestored (via CPR and defibrillation) after the onset of VF, the betterthe chances that the patient 14 will survive the event. Thedefibrillator 10 may be in the form of an AED capable of being used by afirst responder. The defibrillator 10 may also be in the form of amanual defibrillator for use by paramedics or other highly trainedmedical personnel.

A pair of electrodes 16 are applied across the chest of the patient 14by the user 12 in order to acquire an ECG signal from the patient'sheart. The defibrillator 10 then analyzes the ECG signal for signs ofarrhythmia. If VF is detected, the defibrillator 10 signals the user 12that a shock is advised. After detecting VF or other shockable rhythm,the user 12 then presses a shock button on the defibrillator 10 todeliver defibrillation pulse to resuscitate the patient 14.

Recent studies have shown that different patients may be resuscitatedmore effectively with different treatment regimens depending uponvarious factors. One factor which affects the likelihood of success ofdefibrillation is the amount of time that has elapsed since the patientexperienced the arrhythmia. This research has indicated that, dependingon the duration of cardiac arrest, a patient will have a betterprobability of recovery with one protocol as compared to another. If theAED is set up for a less effective protocol for the resuscitation of aparticular patient, that patient's probability of recovery may bereduced. These studies have shown that some of these patients have abetter chance of being resuscitated if CPR is performed first, whichwill start by providing externally driven circulation which may bringthe patient to a condition where application of a shock will besuccessful at restoring spontaneous circulation.

Various attempts have been made to try to make this determination in anautomated way from the patient's vital signs. Since the determination ofwhether a shock is advised begins with analysis of the ECG waveform ofthe patient, these attempts have focused on analyzing the ECG waveformin order to make this determination. One line of studies has looked atthe amplitude of the ECG waveform and found that patients with astronger (higher amplitude) ECG waveform have a better chance ofresuscitation with a defibrillating shock than do patients with a loweramplitude ECG. Since the amplitude of the ECG will generally declinewith the passage of time after the onset of VF, this result isunderstandable. However, this measure is not a fail-proof predictor ofresuscitation success. Another characteristic of the ECG which has beenstudied as a predictor of success is the frequency composition of theECG waveform, with higher frequency content being found to correlatewith resuscitation success. This analysis is done by performing aspectral analysis of the ECG waveform, as by using a fast Fouriertransform processor to perform a spectral analysis of the ECG. This,too, has not been found to be a completely accurate predictor ofsuccess. Other researchers have multiplied amplitude and frequencyinformation of the ECG with each other to produce a weighted highfrequency measurement as a predictor of success, which takes advantageof both characteristics. Accordingly it is desirable to have adefibrillator determine a treatment regimen with a high probability ofsuccess automatically and with high accuracy.

It is further desirable to determine the treatment regimen quickly, assoon as the AED is attached to the patient. Failure to do so can lead toseveral problems. If, for example, a rescuer arrives at the scene withan AED set up to perform CPR first (i.e. prior to defibrillation) andfinds that good CPR is already in progress, a defibrillation shock isunnecessarily delayed. On the other hand, if a rescuer arrives at thescene with an AED set up to deliver a shock-first (i.e. prior to CPR)and finds a long-downtime patient with no CPR in progress, CPR may bedelayed. In each of these situations, the less optimal rescue protocolmay reduce the likelihood of survival.

In addition, fixed intervals of cardiopulmonary resuscitation (CPR)without pause for ECG analysis reduce “hands-off” time but risk delayingdefibrillation in cases of failed shocks and re-fibrillation, withunknown consequence for patient outcomes. Some patients with shockablerhythms during CPR may benefit from an early shock, but interrupting CPRfor analysis could compromise more patients. Thus what is needed is ananalysis algorithm for detecting shockable rhythms with high likelihoodof return of spontaneous circulation (ROSC) that optimizes the durationof CPR. This invention uses two existing algorithms in combination: anAED shock advisory algorithm designed for high specificity, and an indexof ECG rate of change that is indicative of the likelihood of ROSC aftera defibrillation shock. Embodiments of the analysis algorithm aredescribed in co-assigned and co-pending U.S. application Ser. No.11/917,272, entitled “Defibrillator with Automatic Shock First/CPR FirstAlgorithm”, which is herein incorporated by reference.

In addition, it is known that responders often have trouble performingrescue breaths during CPR and that hands-only CPR can be very effective.It is also known that continuous compressions with minimal interruptions(e.g., giving breaths) can result in improved resuscitation. A probleminherent in existing rescue defibrillators is that the defibrillator isunable to determine which CPR protocol to pursue(compressions-and-breaths or compressions-only) for optimal survival.

Because CPR causes artifact in the ECG, reliable determination of onsetof re-fibrillation during CPR is not possible with present technology.Current cardiopulmonary resuscitation guidelines recommend periods ofuninterrupted CPR, hence a pause in CPR to analyze the ECG isundesirable, and might adversely affect patient survival. On the otherhand, in patients who re-fibrillate during CPR, prolonged CPR mayadversely affect survival. Because the fraction of patients who wouldbenefit from a pause in CPR to confirm a shockable rhythm is smallcompared to the majority for whom continued CPR is beneficial, analgorithm that can determine a high likelihood of the presence of ashockable rhythm during CPR artifact (i.e. without a pause) would allowidentifying patients who might benefit from a shock without compromisingresuscitation for the majority of patients.

In accordance with the principles of the present invention, adefibrillator is described which automatically analyzes an ECG waveformand estimates a likelihood of return of spontaneous circulation (ROSC)score. The ROSC score is compared to a threshold to advise a treatmentregimen which is more likely to be successful. The treatment regimen canbe to shock the patient first, then analyze the ECG further and possiblyprovide CPR. Another possible treatment regimen is to provide CPR to thepatient before delivering a shock.

The present invention further exploits the inventors' discovery that theROSC score correlates well with the probability of the patient survival.In particular, the inventors have discovered that a ROSC score thatimproves during a rescue generally indicates a higher likelihood ofpatient survival. Thus, the trend of the ROSC score during rescue may beused to adjust the CPR protocol throughout the rescue in order toimprove the patient's outcome.

The present invention further recognizes that if a patient is in VF itmay be optimal to give hands-only CPR. If a patient is in anon-shockable rhythm, it may be optimal to give compressions plusbreaths. The ROSC score may enhance this by adding value in that the“vitality” of the VF is indicated by the ROSC score. If the ROSC scoreindicates longer down-time (less vitality) it may be that onlycompressions should be provided or breaths and compressions. In the caseof a non-shockable rhythm, it may be that breaths and compressionsshould be provided. For some rhythms (e.g., bradycardia less than 40BPM) breaths may be indicated. In accordance with the principles of theinvention, one object of the invention is to describe a defibrillatorand a method for delivering electrotherapy which utilizes a ROSC scoreto select one of a plurality of CPR modes of operation. For example, thedefibrillator may select a compressions-only mode of CPR operation forROSC scores above a threshold, or may select a compressions-plus-breathmode of CPR operation for ROSC scores below the threshold. The thresholdmay be adjustable to comport with the particular protocol of the localrescue authority.

Another object of the invention is a defibrillator and method whichcompares successive ROSC estimates to determine whether a change from afirst CPR mode of operation to a second CPR mode of operation would bebeneficial to the patient. For example, if the ROSC estimate worsensduring the course of a cardiac rescue, the defibrillator may change theCPR mode of operation from a compressions-only mode to acompressions-plus-breath mode of operation.

Yet another object of the invention is a defibrillator and method whichcalculates successive ROSC estimates prior to and just subsequent to adefibrillating shock, and supplements the shock mode of operation with asupplemental shock based on the comparison. For example, it may bebeneficial to immediately deliver a second shock in what would otherwisebe a single-shock protocol if the subsequent ROSC estimate is higherthan the prior ROSC estimate.

Yet another object of the invention is a defibrillator and method whichcalculates successive ROSC estimates, and issues user feedback based onthe comparison. For example, aural or visual feedback of “Good CPR” or“improving patient” may be issued by the defibrillator if the successiveROSC score is higher than the prior ROSC score.

Yet another object of the invention is a defibrillator and method whichcalculates a ROSC estimate during CPR compressions and determineswhether CPR should be interrupted to deliver an immediate electrotherapyshock. In order to minimize the deleterious effect of an erroneousdetermination, e.g. due to CPR artifact, one embodiment of the inventionconfirms the determination after CPR is interrupted, and thereafteradjusts the determination criteria if the determination was erroneous.The adjustment can be to disable the interruption feature altogether.

Yet another object of the invention is a defibrillator which implementsthe ROSC scoring processor in an efficient manner and which produces aROSC score quickly and conveniently.

IN THE DRAWINGS

FIG. 1 is an illustration of a defibrillator being applied to a patientsuffering from cardiac arrest.

FIG. 2 is a block diagram of a defibrillator constructed in accordancewith the principles of the present invention.

FIG. 3 is a detailed block diagram of a ROSC predictor constructed inaccordance with the principles of the present invention.

FIG. 4 is a graph of patient data illustrating the determination of athreshold which can be used in the ROSC predictor of FIG. 3.

FIG. 5 illustrates the results obtained by the constructed system forfour ECG waveforms with different sensitivity settings.

FIG. 6 illustrates the vRhythm score during clean data (vRclean) andduring CPR corrupted data (vRcpr).

FIG. 7 shows vRhythm during CPR (vRcpr) for the ‘True Continue CPR’cases from FIG. 6.

FIG. 8 shows vRcpr for the ‘True Stop CPR’ cases from FIG. 6.

FIG. 9 shows a procedural flow diagram of decisions for CPR anddefibrillation during a cardiac rescue, using the trends in vRhythmscore and the shock determination algorithm.

FIG. 10 shows a procedural flow diagram of decisions for whether toissue a supplemental defibrillating shock based on the trend of thevRhythm score from just before to just after a first shock.

FIG. 11 illustrates a flow diagram illustrating the use of vRhythmduring a CPR period. In the FIG. 11 embodiment, a ROSC score iscalculated during CPR and causes an interruption of CPR if the scoreindicates that an immediate shock is beneficial. Otherwise, CPRcontinues to the conclusion of the CPR period.

FIG. 2 illustrates a defibrillator 110 constructed in accordance withthe principles of the present invention. For purposes of the discussionthat follows, the defibrillator 110 is configured as an AED, and isdesigned for small physical size, light weight, and relatively simpleuser interface capable of being operated by personnel without hightraining levels or who otherwise would use the defibrillator 110 onlyinfrequently. In contrast, a paramedic or clinical defibrillator of typegenerally carried by an emergency medical service (EMS) responder tendsto be larger, heavier, and have a more complex user interface capable ofsupporting a larger number of manual monitoring and analysis functions.Although the present embodiment of the invention is described withrespect to application in an AED, other embodiments include applicationin different types of defibrillators, for example, manualdefibrillators, and paramedic or clinical defibrillators.

An ECG front end circuit 202 is connected to a pair of electrodes 116that are connected across the chest of the patient 14. The ECG front endcircuit 202 operates to amplify, buffer, filter and digitize anelectrical ECG signal generated by the patient's heart to produce astream of digitized ECG samples. The digitized ECG samples are providedto a controller 206 that performs an analysis to detect VF, shockable VTor other shockable rhythm and, in accordance with the present invention,that performs an analysis to determine a treatment regimen which islikely to be successful. If a shockable rhythm is detected incombination with determination of a treatment regimen that indicatesimmediate defibrillation shock, the controller 206 sends a signal to HV(high voltage) delivery circuit 208 to charge in preparation fordelivering a shock and a shock button on a user interface 214 isactivated to begin flashing. When the user presses the shock button onthe user interface 214 a defibrillation shock is delivered from the HVdelivery circuit 208 to the patient 14 through the electrodes 116.

The controller 206 is coupled to further receive input from a microphone212 to produce a voice strip. The analog audio signal from themicrophone 212 is preferably digitized to produce a stream of digitizedaudio samples which may be stored as part of an event summary 130 in amemory 218. The user interface 214 may consist of a display, an audiospeaker, and control buttons such as an on-off button and a shock buttonfor providing user control as well as visual and audible prompts. Aclock 216 provides real-time clock data to the controller 206 fortime-stamping information contained in the event summary 130. The memory218, implemented either as on-board RAM, a removable memory card, or acombination of different memory technologies, operates to store theevent summary 130 digitally as it is compiled over the treatment of thepatient 14. The event summary 130 may include the streams of digitizedECG, audio samples, and other event data as previously described.

The AED of FIG. 2 has several treatment rescue protocols or treatmentmodes which may be selected during setup of the AED when it is initiallyreceived by the EMS service. One type of protocol is the “shock first”protocol. When the AED is set up for this protocol, the AED will, whenconnected to a patient and activated, immediately analyze the patient'sECG heart rhythm to make a heart rhythm classification. If the analysisdetermines that an arrhythmia treatable with electrical defibrillationis present, typically either ventricular fibrillation (VF) or pulselessventricular tachycardia (VT), the rescuer is informed and enabled todeliver the shock. If it is determined that the arrhythmia is nottreatable with a defibrillation shock, the AED will go into a “pause”mode during which CPR may be performed.

The second type of protocol is the “CPR first” protocol. When the AED isset up for this protocol, the AED will begin operating by instructingthe rescuer to administer CPR to the patient. After CPR is administeredfor a prescribed period of time, the AED begins to analyze the ECG datato see if an arrhythmia treatable with electrical defibrillation ispresent.

In accordance with the principles of the present invention the AED 110has a third setup, which is to initially recommend a treatment protocol,either shock first or CPR first. This is done by the AED which begins byanalyzing the patient's ECG waveform, calculating and evaluating a ROSCscore as described below. From the evaluation of the ROSC score atreatment protocol is recommended. The recommended protocol may beimmediately carried out by the AED, or the recommendation presented tothe rescuer for his or her final decision on the treatment protocol tobe carried out.

FIG. 3 illustrates a portion of the ECG front end circuit 202 andcontroller 206 which operate in accordance with the principles of thepresent invention. As previously mentioned the electrodes 116 provideECG signals from the patient which are sampled (digitized) by an A/Dconverter 20. The digitized ECG signals are coupled to the ECG analysisprocessor circuit in the controller which analyzes the ECG waveform todetermine whether application of a shock is advised. The ECG samples arealso coupled to a treatment decision processor 28 comprised of anoptional downsampler 22, a ROSC calculator 24 and a threshold comparator26. Optional downsampler 22 subsamples the stream of ECG samples to alower data rate. For instance, a data stream of 200 samples/sec may bedownsampled to 100 samples/sec. The ECG data samples are coupled to aROSC calculator 24 which determines a ROSC score from the ECG data. TheROSC score is compared against a threshold by threshold comparator 26 todetermine a mode of treatment which is most likely to lead to asuccessful resuscitation. This mode determination is coupled to the modeselection portion of the controller, which either selects the desiredmode automatically or presents the mode as a recommendation to therescuer who may then either decide to follow the recommended mode or analternate treatment regimen. Although the treatment decision processor28 is shown as a separate element from the controller 206, it isunderstood that the treatment decision processor 28 and the ECG analysisprocessor circuit may be part of control or 206.

The ROSC calculator 24 may be operated in several ways. For one example,the ROSC score is calculated as the mean magnitude of the bandwidthlimited first derivative (or first difference, which is a discrete-timeanalog) of the ECG over a period of a few seconds. Since the bandwidthlimited first derivative may already be calculated for arrhythmiadetection by the controller 206, the additional computation may involveonly the additional calculation of an average absolute value. Thisprocess can be implemented as a real-time measure by means of a movingaverage requiring only one addition and one subtraction per sample. Forinstance, the difference of successive samples may be taken for a streamof samples received over a period of 4.5 seconds at a 100 sample/secrate. The signs of the differences are discarded to produce absolutevalues, which are summed over the 4.5 second period. This produces aROSC score value which is equivalent to a frequency-weighted averageamplitude of the ECG waveform. The score may be scaled or furtherprocessed in accordance with the architecture and demands of the instantsystem.

Since the spectrum of the first derivative is proportional to frequency,the ROSC score is largely unaffected by CPR artifact, most of which willbe very low frequency. Thus, a ROSC score calculated in this way iscapable of providing meaningful information about the vitality of thepatient's heart during CPR.

Another alternative way to calculate a mean value is to square thedifferences of the consecutive samples, then sum the products and takethe square root of the sum. This produces an RMS (root mean square) formof ROSC score.

As an alternative to the mean value computation, another approach is touse the median magnitude of the first derivative. This approach is morecomputationally intensive, but can advantageously be more robust tonoise. Care must be taken to avoid de-emphasizing the signal that givesthe measure its discriminating power. In another embodiment, a trimmedmean or min-max calculation can offer a favorable compromise. Byeliminating the largest outliers, greater immunity to impulse artifacts(e.g. physical disturbances of the electrode pads) can be provided. Byeliminating the largest outliers, the occasional high amplitude artifactwhich would occur relatively infrequently can be eliminated withoutsignificantly reducing the discriminating power associated with the dataof cardiac origin.

An AED has been constructed to operate in accordance with the presentinvention. The inventors have discovered that the implemented ROSC scoreprocessor identifies ECG rhythms which result in ROSC followingimmediate defibrillation with high sensitivity, e.g., around 90%, andspecificity greater than 60%. Sensitivity (Sn) is the percentage ofpatients that would achieve ROSC in response to an immediatedefibrillation shock, that are correctly identified by the ROSC score.Specificity is the percentage of patients that would not achieve ROSC inresponse to an immediate defibrillation shock, that are correctlyidentified by the ROSC score. Sensitivity and specificity with respectto ROSC may be traded off in approximately equal proportion.

An implementation whereby alternative setup sensitivities were madeavailable to the user is shown by the graph of FIG. 4. A database wasassembled of the results of patients treated with defibrillation, someof whom achieved ROSC in response to an initial defibrillation shock andsome of whom did not. The patients were treated after varying cardiacarrest durations. The ROSC score calculated by the implemented systemwas in the range of 2.5 to 40.0 units, where each unit corresponds to0.25 mV/sec. The more lightly shaded portions of the bars in the graphindicate patients in the database who exhibited ROSC after delivery of ashock. The more darkly shaded portions of the bars indicate patients whodid not exhibit ROSC after treatment. The graph shows the results ofROSC scoring by the system, which exhibited a 95% sensitivity to ROSCfollowing an initial shock for patients with ROSC score greater than 3.0mV/sec (i.e. 12.0 units), and a sensitivity of 85% for patients withROSC score greater than 3.6 mV/sec (i.e. 14.4 units). Below a ROSC scoreof about 2.5 mV/sec (i.e. 10 units), 100% of the patient populationfailed to achieve ROSC as the result of a first shock and may havebenefited from a CPR first regimen of treatment. In the implementedsystem two thresholds of different sensitivities were used, one of 95%sensitivity and the other of 85% sensitivity. The user is thus able toselect a desired sensitivity during setup of the AED and can favorgreater use of shock first with selection of the higher sensitivity(95%) or greater use of CPR first with a lower sensitivity (85%).

The implemented system has also been found to identify a good outcomepopulation for patients treated with a shocks-first protocol,experiencing neurologically intact survival of 53%, (95% CI [40%, 67%]).The implemented system also identified a poor outcome group thatachieved neurologically intact survival of only 4%, (95% CI [0.1%, 20%])and who might therefore benefit from CPR-first resuscitation.

FIG. 5 illustrates the results obtained by the constructed system forfour ECG waveforms with different sensitivity settings. In the Auto 1(higher) sensitivity setting 300, a shock-first is advised in responseto the first three ECG waveforms 340, 350, 360 and CPR-first is advisedfor the fourth 370. In the Auto 2 (lower) sensitivity setting 320 ashock-first is advised for the first ECG waveform 340 and CPR-first isadvised for the other three ECG waveforms 350, 360, 370.

An alternative embodiment to the invention uses an AED shock advisoryalgorithm designed for high specificity, and an index of ECG rate ofchange (called vRhythm, as described in U.S. patent application Ser. No.11/917,272) that is indicative of the likelihood of ROSC after adefibrillation shock. In artifact free ECG, at first presentation of apatient in VF, these two algorithms are used to advise either animmediate shock or an initial interval of CPR. In this case if the AEDshock advisory algorithm indicates a shockable rhythm, the vRhythm scoreis compared to a threshold value—if it is greater than or equal to thethreshold, a shock is advised, and if less than the threshold CPR isadvised. A database of resuscitations has shown that for initialshockable rhythms with vRhythm below a threshold of 14.5 units, patientsare very unlikely to survive if shocked immediately, and therefore maybenefit from an initial period of CPR.

As the resuscitation progresses, after a defibrillation shock has beendelivered, present protocols recommend a continuous interval ofuninterrupted CPR (typically 2 minutes). It is common however for apatient to re-fibrillate during the CPR interval. The presence of avigorous VF waveform in the ECG may indicate a high likelihood of ROSCif a shock were to be given immediately, whereas for the same patient,continued CPR may result in a decrease in the likelihood of ROSC.Because the fraction of patients who may benefit from an immediate shockis much less that those that would benefit from continuous CPR, pausingCPR to accurately assess the patient rhythm would interrupt CPR andpossibly decrease the survival of many more patients than it would help.

This embodiment applies an AED shock advisory algorithm and the vRhythmscore during CPR corrupted ECG after an initial or subsequent shock, inorder to evaluate the likelihood of a vigorous shockable rhythm withoutceasing CPR. If there is a high likelihood of a shockable rhythm asindicated by a high vRhythm score, CPR would be stopped, and a shockdelivered after a confirming analysis in artifact free ECG. Futurealgorithm enhancements that identify very high likelihood of a shockablerhythm during CPR may allow shock delivery without an interveningconfirmatory analysis. This embodiment would therefore allow deliveringan immediate shock to patients whose survival may be improved by animmediate shock, without compromising resuscitation of other patientswho may benefit more by continuing CPR.

Turning now to FIG. 6, an implementation of the present invention hasbeen evaluated using the Philips Patient Analysis System (PAS) shockadvisory algorithm, in conjunction with the Philips vRhythm score.Improvements in performance of the reported embodiment may be gainedthrough simple modification of each of these algorithms within the scopeof this description. To evaluate performance, an ECG database, adaptedfrom the “Sister's” database compiled by Laerdal Medical, WappingerFalls, N.Y., includes ECG data from resuscitations with a wide varietyof rhythms representative of those expected in practice. The databasecontains 20-second ECG strips, the first 10 seconds recorded during CPR,followed by 10 seconds after CPR cessation. Measurements and resultsfrom the algorithms for these two data segments will be referred to inthis description by subscripts ‘cpr’ and ‘clean’.

The PAS results and vRhythm score were used on data from the clean ECGsegment to establish a ‘truth annotation’ for each case in the database.In conformance with the previous Philips vRhythm invention, cases forwhich the PAS result indicated ‘shock advised’ and for which the vRhythmscore was greater than or equal to 14.5 were annotated as ‘true’ forhigh likelihood of benefit from ceasing CPR for delivery of adefibrillation shock (referred to hereafter as ‘True Stop CPR’). Becausethe CPR and clean data segments are continuous in time, this truthannotation determined in the clean data is assumed to also be true forthe CPR corrupted data (i.e. the underlying rhythm is assumed not tochange during the 20 second recording). Hence this database allows us toevaluate performance in the CPR corrupted data and compare it to the‘truth’ determined from the clean ECG data.

FIG. 6 shows the vRhythm score during clean data (vRclean) and duringCPR corrupted data (vRcpr) for all 363 cases in the database. The caseshave been sorted for increasing vRclean and PAS decision in the cleandata segment (PASclean). For cases 1-263 PASclean was no shock, and forcases 264-363 PASclean was shock (100 cases). Cases 324-363 (40 cases)met the criteria for ‘True Stop CPR’, i.e. rhythms for which the patientwould be judged likely to benefit from an immediate shock instead ofcontinued CPR. The remaining cases (1-323) are ‘False Stop CPR’, or alsoreferred to as ‘True Continue CPR’.

FIG. 6 also shows vRcpr in direct comparison with the vRclean value. Thefigure shows that CPR artifact biases the vRhythm score toward largervalues. To accommodate this bias, for vRhythm evaluated during CPR, thisimplementation raises the threshold for indicating an immediate shock togreater than or equal to 19 (instead of the 14.5 threshold for cleandata). Also note that there are several extreme values of vRcpruncharacteristic of values for vRclean. Hence this implementationincludes a vRcpr threshold of 50, above which CPR will not beinterrupted.

Turning now to FIG. 7, shown is vRhythm during CPR (vRcpr) for the ‘TrueContinue CPR’ cases from FIG. 6. In FIG. 7 the data is sorted by vRcprand by PAS decision for the CPR corrupted data segment (PAScpr). Thisdata allows determining false positive and true negative Stop CPRperformance. There are 11 false positive cases (310-320) for which(PAScpr=shock) and (19<vRcpr<=50). There are 312 true negative cases:(1-309) and (321-323).

FIG. 8 shows vRcpr for the ‘True Stop CPR’ cases from FIG. 6. In FIG. 8the data is sorted by vRcpr and by PAS decision for the CPR corrupteddata segment. This data allows determining true positive and falsenegative Stop CPR performance. There are 19 false negative cases: cases1-14 because PAScpr=no shock and cases 15-19 because vRcpr <19. Thereare 21 true positive Stop CPR cases (20-40).

Combined, the performance data from FIGS. 7 and 8 can be used tocalculate the sensitivity, specificity, and positive predictivity of thecriteria that, during CPR, predict the cases from this database forwhich interrupting CPR to deliver a rescue defibrillation shock would bepotentially beneficial. The data indicate the following:sensitivity=53%; specificity=97%; positive predictivity=66%.

For CPR periods of the prior art defibrillators, CPR must be eithercontinuous for all patients, or interrupted for all patients to assessthe need to deliver of a defibrillation shock. For continuous CPR, 323cases from this dataset would receive the most likely optimal therapy(89%), and 40 cases that may benefit from an early shock would receivesuboptimal therapy (11%). Interrupting all rescues for assessing theneed to deliver a shock would result in suboptimal therapy for 323 cases(89%), and more optimal therapy for 40 cases (11%). In accordance withthe present invention, however, CPR would be interrupted for 32 cases(21 true positive and 11 false positive, 9%); and CPR would becontinuous for 331 cases (19 false negative and 312 true negative).Therapy would be optimal in 333 cases (21 true positive and 312 truenegative, 92%), and suboptimal in only 30 cases (11 false positive and19 false negative, 8%). Thus, the overall performance of the inventivevRhythm algorithm that determines a ROSC score during CPR results inbetter performance than the prior art CPR protocols. For the purposes ofclarity, the term “ROSC score” is used hereafter to refer to the vRhythmscore determined by the vRhythm algorithm as described above.

It is well known to those skilled in the art that adjustments to thealgorithm criteria will alter these performance statistics. It is alsowell known that the performance criteria depend on the relativeincidence of rhythms in the database on which they are calculated. Thisdatabase appears representative of many emergency response systemsthroughout the world for which survival from cardiac arrest is very low,hence the low incidence of cases for which stopping CPR might bebeneficial. For other systems with shorter response times, and hencehigher survival rates, the incidence of cases for which stopping CPRmight be beneficial will be higher, and the benefit of the algorithmwill be correspondingly greater.

In an alternative embodiment of the invention, for example, thealgorithm could be adjusted to calculate scores only during detectedshort breaks in the CPR compressions, i.e. when low artifact noiselevels occur. The detection could be obtained through secondaryindicators of motion, such as a chest-applied accelerometer, common modecurrent, transthoracic impedance changes, or via ECG signal analysis.Enough data may be accumulated during a sufficient number of these shortbreaks to indicate a likelihood that refibrillation has occurred duringCPR. If so indicated, the AED could direct a pause for further analysis.If a false negative has improperly caused the AED to foreshorten CPR,then the analysis may be additionally adjusted, filtered, or shut offentirely for subsequent CPR periods.

This embodiment of the invention evaluated one set of criteria. Otherembodiments may alter these criteria, or modify the two algorithms towhich the criteria are combined. For example, the shock advisoryalgorithm may be adjusted to produce fewer false negative cases byaltering criteria within it, and the vRhythm calculation may also bemodified (e.g. modified bandwidth) to further suppress the effects ofCPR artifact on the ROSC score. Previous ROSC scores, including thepresenting ROSC score, may also be used as input to a decision onwhether to interrupt CPR for a defibrillation shock. Furthermore, thisembodiment of the invention has used only ECG data in its estimation ofthe need to deliver a defibrillation shock. Other signals, gatheredsimultaneously with the ECG (e.g. patient small-signal impedance, commonmode current, and chest wall acceleration during CPR) may allow furtheroptimization of an embodiment of the invention.

Turning now to FIG. 9, a flow chart showing automatic decision-makingcriteria in an AED is shown. Organizations continue to emphasize simplerCPR in an effort to increase survival and encourage bystanders to act. fhands-only CPR is a better alternative (for the particular rhythm) thenthat would help simplify CPR. If breaths are not necessary, it willminimize interruptions for giving breaths and promote survival. Therescue protocol described in the flow chart takes into account theseprinciples to offer simpler and more effective CPR when possible.

In FIG. 9, once the electrodes are attached to the cardiac arrestpatient, the AED obtains an ECG at step 900. At step 902, the AEDemploys its analysis algorithm to determine whether the ECG is shockableor not and employs its vRhythm algorithm, as described previously, tocalculate a ROSC score VR1. If the rhythm is non-shockable, step 904,the AED enters a first CPR mode of operation, defined as CPR with rescuebreaths and compressions at step 906. If the ECG is shockable, then theROSC score VR1 is compared to a threshold score at step 908. If the ROSCscore VR1 is low, then the AED enters a shock-first protocol, andimmediately directs the first CPR mode of operation at step 910 followedby a defibrillating shock at step 912 and another period of first CPRmode of operation at step 914.

If the ECG is shockable with a ROSC score above threshold at step 908,then the AED immediately directs a shock at step 916 followed by asecond CPR mode of operation at step 918. Here, the second CPR mode ofoperation is defined as CPR with compressions only. The reason for thisdecision is that a patient having a high ROSC score VR2 may benefit morefrom compressions-only CPR.

FIG. 9 also shows that following the first shock/CPR interval, the ECGis again analyzed at step 920. The AED calculates a second ROSC scoreVR2, and compares VR2 with the first ROSC score VR1 at decision step924. An increase in ROSC score indicates “good” CPR and/or improvingchance of survival. Thus, after a shock, if the ROSC score increases,then the AED continues the second CPR mode of operation at step 928. Adecreasing ROSC score, however, indicates a worsening chance ofsurvival, perhaps exacerbated by “poor” CPR. If the ROSC score falls,then, the AED directs a change to the first CPR mode of operation atstep 926.

For a non-shockable presenting ECG, the AED applies at step 906 thefirst CPR mode of operation without a defibrillating shock. After theCPR period, the AED repeats the ECG analysis and calculates a subsequentROSC score VR2 at Step 930. The AED then compares VR2 with the firstROSC score VR1 at decision step 932. An increase in ROSC score indicates“good” CPR and/or improving chance of survival. Thus, if the ROSC scoreincreases, then the AED continues the second CPR mode of operation atstep 934. A decreasing ROSC score, however, indicates a worsening chanceof survival, perhaps indicating that CPR is ineffective. Thus a fallingROSC score in this arm causes the AED to change from a first CPR mode ofoperation to an alternate therapy at step 936. The alternate therapycould be the second CPR mode of operation, or directing the use ofpharmaceutical therapy such as epinephrine, hypothermia therapy or otherknown cardiac rescue techniques.

At the end of any of the protocol branches indicated by the circled “1”in FIG. 9, the cardiac rescue may progress in accordance with prior artprotocols. More preferably, the inventive method may be continued byreturning to step 900 for further subsequent analysis. Repetition of themethod throughout the rescue enables the continued adjustment of therescue protocol as warranted by a change in the patient's ECG. Furtheradjustment of the ROCS score thresholds or decision criteria couldoccur, for example, when step 900 is re-entered following a confirmedapplication of the alternate therapy at step 936.

Another embodiment of the invention is shown in the flow chart of FIG.10. FIG. 9 illustrates a conventional shock delivery protocol having apre-set number of shocks to be delivered prior to the next CPR period;in this instance a single-shock protocol. The inventors have discoveredthat a ROSC score which is calculated immediately following the shockcan indicate whether or not a supplemental shock would benefit thepatient prior to entering the CPR period. In effect, this embodimentuses the ROSC score to adjust the number of shocks to be delivered in aseries prior to continuing the rescue.

FIG. 10 shows a modified decision process which is inserted between theFIG. 9 step 916 and step 918 Immediately following the shock at step916, the AED obtains ECG data and calculates a subsequent ROSC scoreVR1′ at step 1016. The AED then compares VR1′ with the first ROSC scoreVR1 at decision step 1018. An increase in ROSC score indicates animproving chance of survival even if the ECG rhythm has not beenconverted by the shock, so a supplemental shock may be warranted. TheAED thus arms and directs a supplemental shock to be delivered prior toinitiating the CPR period of step 918. A worsening ROSC score detectedat step 1018, however, may indicate that immediate CPR is better for thepatient. In this case, the AED initiates CPR step 918 without furtherdelay.

Yet another embodiment of the invention is shown in the flow chart ofFIG. 11. FIG. 11 illustrates the use during a CPR period of a ROSC scoreVR3 to optimize therapy in accordance with the discoveries of FIGS. 7and 8. Here shown is the CPR period of FIG. 9 step 910 although it isunderstood that the inventive method may be incorporated into any or allof the CPR periods herein described.

The embodiment of FIG. 11 illustrates an AED treatment decisionprocessor which captures ECG data during the CPR period 910. The AEDcalculates a ROSC score VR3 at step 1110 and compares VR3 to a thresholdat step 1112. A ROSC score VR3 below the threshold indicates a lowprobability of a shockable rhythm. The AED in this case thus directs thecontinued application of CPR at step 1114.

A ROSC score VR3 above the threshold, however, indicates a highlikelihood of a shockable rhythm, i.e. sufficiently vigorous to beconverted by immediate shock. The AED in this event directs theinterruption of CPR at step 1116 by means of the aural and/or visualoutputs of user interface 214. The AED subsequently detects thecessation of CPR in step 1118, by any of the previously describedmethods including common mode current, patient impedance or secondarychest wall compressions sensors. Then the AED analyzes the ECG data toconfirm the presence of a shockable rhythm at step 1120.

If a shockable rhythm is confirmed in step 1122 of FIG. 11, the AED armsand directs the application of a defibrillating shock in step 1124.After the shock is delivered, CPR is resumed at step 1126 until the endof the CPR period.

The analysis step 1120 may instead indicate that ROSC score VR3 is afalse positive caused by CPR artifact. In this case, it is importantthat the false positive does not recur in subsequent CPR periods inorder to ensure uninterrupted compressions. So the AED responds to afalse positive ROSC score VR3 by directing the immediate resumption ofCPR in step 1128. In addition, the AED preferably reduces thesensitivity of the ROSC scoring threshold used in step 1112 at step1130.

Alternatives to the aforedescribed procedure are envisioned by thisinvention. For example, the CPR mode of operation directed by the AED inthe presence of a shockable, low initial ROSC score might be the firstCPR mode of operation instead of the second CPR mode of operation. TheCPR mode of operation directed by the AED, after the shock and in thepresence of a degrading (i.e. falling) vRhythm score might be the secondCPR mode of operation instead of the first CPR mode of operation. Thesealternatives would be employed based upon an assessed quality of CPR.

Another alternative is to employ a threshold score as the decisioncriteria for changing the first CPR mode of operation to the second CPRmode of operation, instead of using a mere increasing or decreasingscore criteria. This technique would likely result in fewer adjustmentsin CPR mode of operation, which could reduce confusion during the rescuesomewhat. In addition, using a threshold comports somewhat more closelywith the analytical basis of the invention.

What is claimed is:
 1. A defibrillator comprising: an ECG front endcircuit coupled to a source of ECG signals; and a controllercommunicatively coupled to the ECG front end circuit, comprising an ECGdata analysis circuit responsive to the ECG signals which analyzes ECGdata to determine whether a shock is recommended or a shock is notrecommended; and a treatment decision processor responsive to the ECGsignals which acts to estimate a first probability of resuscitation froma shock and a subsequent probability of resuscitation from a shock; anda defibrillator mode circuit responsive to the ECG data analysis circuitand the treatment decision processor which is operable to set thedefibrillator to a shock mode or a CPR mode of operation and which isfurther operable to change a CPR mode of operation from one of aplurality of CPR modes of operation to another one of a plurality of CPRmodes of operation based on a change from the first probability to thesubsequent probability, wherein the plurality of CPR modes of operationcomprises a compressions-only mode and a compressions-plus-breaths modeof operation, and further wherein the defibrillator mode circuit changesthe CPR mode of operation from a compressions-only mode to acompressions-plus-breaths mode of operation if the subsequentprobability is lower than the first probability.
 2. The defibrillator ofclaim 1, wherein the treatment decision processor comprises a ROSCcalculator which estimates the first and subsequent probabilities ofresuscitation as a first ROSC score and a subsequent ROSC score.
 3. Thedefibrillator of claim 1, wherein the defibrillator mode circuitalternates the shock mode of operation with the CPR mode of operationregardless of which of the plurality of CPR modes of operation isselected.
 4. The defibrillator of claim 1, further comprising a userinterface, responsive to the controller, which outputs user informationrelating to the change from the first probability to the subsequentprobability.
 5. A defibrillator comprising: an ECG front end circuitcoupled to a source of ECG signals; and a controller communicativelycoupled to the ECG front end circuit, comprising an ECG data analysiscircuit responsive to the ECG signals which analyzes ECG data todetermine whether a shock is recommended or a shock is not recommended;and a treatment decision processor responsive to the ECG signals whichacts to estimate a first probability of resuscitation from a shock and asubsequent probability of resuscitation from a shock; and adefibrillator mode circuit responsive to the ECG data analysis circuitand the treatment decision processor which is operable to set thedefibrillator to a single-shock mode or a CPR mode of operation andwhich is further operable to supplement the single-shock mode ofoperation with one additional shock to be delivered prior to asubsequent CPR period based on a change from the first probability tothe subsequent probability.
 6. The defibrillator of claim 5, wherein thedefibrillator mode circuit supplements the shock mode of operation ifthe subsequent probability is higher than the first probability.
 7. Thedefibrillator of claim 4, wherein the user interface outputs auralinformation.
 8. The defibrillator of claim 4, wherein the user interfaceoutputs visual information.
 9. A method for delivering electrotherapyfrom a defibrillator comprising the steps of: receiving patient ECGsignals; determining from the ECG signals the presence of an arrhythmiatreatable by the defibrillator; estimating from the ECG signals a firstprobability of resuscitation shock success; selecting a treatmentprotocol based upon both of the determined treatable arrhythmia and theestimated first probability of resuscitation; estimating from subsequentECG signals a subsequent probability of resuscitation shock success;comparing the first and subsequent probabilities of resuscitation shocksuccess; and selecting a second treatment protocol if the subsequentprobability is lower than the first probability from the comparing step,wherein the treatment protocol is a compressions-only mode of CPRoperation and the second treatment protocol is acompressions-plus-breaths mode of CPR operation.
 10. The method of claim9, further comprising; delivering a supplementary electrotherapeuticshock based upon the comparing step.
 11. The method of claim 10, furthercomprising the step of wherein estimating further comprises computing aROSC score.
 12. The method of claim 10, wherein estimating furthercomprises comparing the ROSC score to a threshold.